Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma

Not Recruiting

Trial ID: NCT00134030

Purpose

This randomized phase III trial is studying combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving combination therapy together with PEG-interferon alfa-2b is more effective than two different combination chemotherapy regimens alone after surgery in treating osteosarcoma.

Official Title

A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-operative Chemotherapy

Stanford Investigator(s)

Eligibility


Inclusion Criteria:

   - Histologically confirmed high-grade osteosarcoma, including second malignancies

      - Localized or metastatic disease

      - The primary tumor must be located in the limbs or axial skeleton, including any
      of the following sites*:

         - Long bone of upper limb

         - Short bone of upper limb

         - Long bone of lower limb

         - Short bone of lower limb

         - Vertebral column

         - Ribs, sternum, clavicle, or scapula

         - Pelvic bones, sacrum, or coccyx

   - Tumor (primary, metastatic, or both) resectable OR is expected to become resectable
   after neoadjuvant induction chemotherapy

   - Suitable for neoadjuvant chemotherapy

   - Performance status - Lansky 50-100% (for patients under 16 years of age)

   - Performance status - Karnofsky 50-100%*

   - Performance status - WHO or ECOG 0-2*

   - Platelet count ≥ 100,000/mm³

   - Neutrophil count ≥ 1,500/mm³

   - WBC ≥ 3,000/mm³

   - Bilirubin ≤ 1.5 times upper limit of normal

   - Creatinine clearance ≥ 70 mL/min

   - Creatinine based on age as follows:

      - No greater than 1.0 mg/dL (for patients 5 to 10 years of age)

      - No greater than 1.2 mg/dL (for patients 11 to 15 years of age)

      - No greater than 1.5 mg/dL (for patients over 15 years of age)

   - Ejection fraction ≥ 50% by radionuclide angiogram

   - Shortening fraction ≥ 28% by echocardiogram

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - No known HIV positivity

   - No prior chemotherapy for any disease

   - Prior radiotherapy for another malignancy allowed

   - No prior treatment for osteosarcoma

   - No patients with any of the following:

      - Craniofacial osteosarcoma

Intervention(s):

drug: cisplatin

drug: doxorubicin hydrochloride

drug: etoposide

drug: ifosfamide

drug: methotrexate

biological: peginterferon alfa-2b

procedure: therapeutic conventional surgery

other: questionnaire administration

other: Quality-of-Life Assessment

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535

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